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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Non-Propagating Transport
510(k) Number K240235
Device Name OmniTrans Transport System
Applicant
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Rm.702-703, Bldg. #1, Shenzhen Biomedicine Innovations
Industrial Pk, #14 Jinhui Rd., Kengzi St., Pingshan District
Shenzhen,  CN 518122
Applicant Contact Wei Jiang
Correspondent
Shenzhen Dakewe Bio-Engineering Co., Ltd.
Rm.702-703, Bldg. #1, Shenzhen Biomedicine Innovations
Industrial Pk, #14 Jinhui Rd., Kengzi St., Pingshan District
Shenzhen,  CN 518122
Correspondent Contact Wei Jiang
Regulation Number866.2390
Classification Product Code
JSM  
Date Received01/29/2024
Decision Date 08/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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